Manufacturer registered with FDA
Hans Korea
Paju-si, South Korea. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 57 registrations outside the US
- Establishments
- 1South Korea
Registered in 5 markets
Where regulators' registries name Hans Korea as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hans Korea | 5 device types | — | Below |
| Taiwan | TFDA | Manufacturer | HANS KOREA CO., LTDHANS KOREA | 3 | 2015–2023 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | HANS Korea Co., Ltd. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HANS KOREA CO., LTD | 1 | 2023–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | HANS KOREA CO, LTD | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Hans Korea currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Hans Korea | 2011 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | ICTICT 2D LONGICT MICROICT NANOICT POCKETICT POCKET SHORTICT-DELTAICT-DELTA SHORTSinustop | 2013 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | Hans Korea | 2011 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | NiTi Brush OMEGA SHORTNiTi Brush Perio Saw'NiTi Brush OMEGA | 2020 |
| Fixture Mount KitNYE · Class 1 | Implant instruments & surgical kits | Maker | Hans Korea | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HANS KOREAFDA reg. 3009142026 | Paju-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10036445). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.